Sight Sciences has received FDA 510(k) clearance for its OMNI Ultra Surgical System, a next-generation implant-free device for reducing intraocular pressure in adults with primary open-angle glaucoma. The system enables canaloplasty followed by trabeculotomy through a single clear corneal microincision and is the first FDA-cleared minimally invasive glaucoma surgery device for circumferential canaloplasty in a single pass. It features TruSync Plus technology for enhanced control and precision during viscodilation, and preserves the flexibility of the OMNI platform for use in standalone or cataract-combined procedures. The company plans a U.S. commercial launch in the fourth quarter of 2026, building on a platform used in more than 350,000 procedures worldwide.
Sight Sciences IncFDA clearance for OMNI Ultra Surgical System, a next-generation device, with planned U.S. launch.
